Functional DysphoniaNCT06559748
A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia
A study testing transcranial magnetic thetaburst stimulation （TBS） in people with Functional Dysphonia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The goal of this clinical trial is to learn if theta burst stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), can treat functional dyspepsia (FD) and compare its effectiveness against conventional drug treatments in patients diagnosed with FD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dysphonia
- What is being tested?
- transcranial magnetic thetaburst stimulation （TBS）
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years old, regardless of gender, outpatients.
- Meets the Rome IV diagnostic criteria for functional dyspepsia in gastroenterology (2016 edition).
- There are symptoms of postprandial fullness discomfort, early satiety discomfort, mid-upper abdominal pain, and mid-upper abdominal burning discomfort, with at least one score (degree + frequency) ≥ 4 points; the total score is ≥ 10 points. Note: See the case report form for the scoring table.
- Agree to participate in this clinical trial and sign the informed consent form.
Who cannot join
- Those who suffer from organic gastrointestinal diseases such as reflux esophagitis, peptic ulcer, gastrointestinal tumors, etc., or who are suspected of having intestinal obstruction.
- Patients with intracranial hypertension, epilepsy, severe heart disease, other serious physical diseases or cognitive dysfunction; pregnant and lactating women.
- ALT and AST are greater than 1.5 times the normal value, total bilirubin exceeds 1.5 times the upper limit of the normal value, and creatinine exceeds the upper limit of the normal value;
- Suspected or confirmed history of drug or alcohol abuse;
About this study
Official title: A Multi-arm Randomized Controlled Trial of Transcranial Magnetic Theta-burst Stimulation in the Treatment of Functional Dyspepsia
The goal of this clinical trial is to learn if theta burst stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), can treat functional dyspepsia (FD) and compare its effectiveness against conventional drug treatments in patients diagnosed with FD. The main questions it aims to answer are:
Does TBS improve FD-related symptoms and associated mental health conditions such as anxiety and depression? How does the effectiveness of TBS compare to conventional drug treatments for FD?
Read more
Researchers will compare TBS treatment, sham TBS treatment, and conventional drug treatment to see if TBS is effective in treating FD. Participants will:
Undergo TBS or sham TBS treatment, or take conventional medications as prescribed.
Have their FD symptoms, anxiety, and depression levels assessed before and after the treatment.
Be evaluated at various intervals (Day 3, Month 1, Month 3, Month 6) for symptom improvement and side effects.
Participants are adults aged 18-70, diagnosed with FD, and willing to participate in this study. They will be randomly assigned to one of the three groups: TBS, sham TBS, or conventional drug treatment, with an equal number of participants in each group.
The study will be conducted over two years, from November 1, 2023, to October 31, 2025, at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Read the detailed description
Background:
Functional dyspepsia (FD) is a prevalent gastrointestinal disorder characterized by upper abdominal discomfort, including symptoms such as pain, bloating, early satiety, belching, and nausea. The etiology of FD is multifactorial, with psychosocial factors playing a significant role in its development. Recent advances in understanding the brain-gut axis have highlighted the potential of non-invasive neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), to modulate brain activity and alleviate FD symptoms.
TMS, particularly theta burst stimulation (TBS), has shown promise in treating various neurological and psychiatric disorders. This study aims to explore the efficacy of TBS in improving both gastrointestinal symptoms and associated psychological symptoms in patients with FD, providing a novel therapeutic option for this challenging condition.
Objective:
The primary objective of this study is to compare the efficacy of TBS, sham TBS, and conventional pharmacological treatments in alleviating the symptoms of functional dyspepsia. The study seeks to determine whether TBS can offer superior symptom relief compared to standard treatment methods.
Study Design:
This is a single-center, randomized controlled clinical trial with 2 parallel arms: TBS treatment, and conventional drug therapy. Participants will be randomly assigned to one of the 2 groups in a 1:1 ratio. The study will be conducted over two years, from November 1, 2023, to October 31, 2025.
Intervention:
- TBS Group: Participants will receive iTBS stimulation of the right medial frontal cortex (RMFC) at 80-100% of their resting motor threshold (RMT), with 10 sessions per course, administered twice daily for five days.
- Conventional Drug Group:Participants will receive pantoprazole (40 mg orally once daily) and itopride (50 mg orally three times daily) for four weeks.
Participants:
The study will enroll 150 adult outpatients (aged 18-70 years) diagnosed with functional dyspepsia according to the Rome IV criteria. Participants will be screened based on specific inclusion and exclusion criteria and will provide informed consent before enrollment.
Data Management and Statistical Analysis:
All data will be collected and analyzed using SPSS 19.0 software. The analysis will include t-tests for normally distributed data and non-parametric tests for non-normally distributed data. The study will also employ multifactor ANOVA to assess the impact of various factors on treatment outcomes.
Ethical Considerations:
The study will be conducted in accordance with ethical standards, ensuring participant confidentiality and safety. Adverse events will be closely monitored and reported to relevant regulatory bodies.
This study aims to provide evidence for the clinical efficacy of TBS in treating FD, potentially offering a new therapeutic approach for managing brain-gut axis-related disorders.
- Conditions
- Functional Dysphonia
- Being tested
- transcranial magnetic thetaburst stimulation （TBS）
- Keywords
- Functional Dysphonia，Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic thetaburst stimulation （TBS）Device
Also called Conventional drugs
TBS group: iTBS was administered to stimulate RMFC, 80-100% RMT, 10 times a course, twice a day, for a total of 5 days; Conventional drugs group: pantoprazole 40 mg orally once a day; itopride 50 mg orally three times a day; treatment for 4 weeks. （Standard medication regimen）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559748
- Sponsor's protocol ID
- 2023-0802
- Status last verified
- Jul 2024
- First submitted
- 8 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-arm Randomized Controlled Trial of Transcranial Magnetic Theta-burst Stimulation in the Treatment of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT06559748
- Acronym / sponsor ID
- 2023-0802
- Conditions
- Functional Dysphonia
- Keywords
- Functional Dysphonia，Transcranial Magnetic Stimulation
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if theta burst stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), can treat functional dyspepsia (FD) and compare its effectiveness against conventional drug treatments in patients diagnosed with FD. The main questions it aims to answer are:
Does TBS improve FD-related symptoms and associated mental health conditions such as anxiety and depression? How does the effectiveness of TBS compare to conventional drug treatments for FD?
Researchers will compare TBS treatment, sham TBS treatment, and conventional drug treatment to see if TBS is effective in treating FD. Participants will:
Undergo TBS or sham TBS treatment, or take conventional medications as prescribed.
Have their FD symptoms, anxiety, and depression levels assessed before and after the treatment.
Be evaluated at various intervals (Day 3, Month 1, Month 3, Month 6) for symptom improvement and side effects.
Participants are adults aged 18-70, diagnosed with FD, and willing to participate in this study. They will be randomly assigned to one of the three groups: TBS, sham TBS, or conventional drug treatment, with an equal number of participants in each group.
The study will be conducted over two years, from November 1, 2023, to October 31, 2025, at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Detailed description
Background:
Functional dyspepsia (FD) is a prevalent gastrointestinal disorder characterized by upper abdominal discomfort, including symptoms such as pain, bloating, early satiety, belching, and nausea. The etiology of FD is multifactorial, with psychosocial factors playing a significant role in its development. Recent advances in understanding the brain-gut axis have highlighted the potential of non-invasive neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), to modulate brain activity and alleviate FD symptoms.
TMS, particularly theta burst stimulation (TBS), has shown promise in treating various neurological and psychiatric disorders. This study aims to explore the efficacy of TBS in improving both gastrointestinal symptoms and associated psychological symptoms in patients with FD, providing a novel therapeutic option for this challenging condition.
Objective:
The primary objective of this study is to compare the efficacy of TBS, sham TBS, and conventional pharmacological treatments in alleviating the symptoms of functional dyspepsia. The study seeks to determine whether TBS can offer superior symptom relief compared to standard treatment methods.
Study Design:
This is a single-center, randomized controlled clinical trial with 2 parallel arms: TBS treatment, and conventional drug therapy. Participants will be randomly assigned to one of the 2 groups in a 1:1 ratio. The study will be conducted over two years, from November 1, 2023, to October 31, 2025.
Intervention:
- TBS Group: Participants will receive iTBS stimulation of the right medial frontal cortex (RMFC) at 80-100% of their resting motor threshold (RMT), with 10 sessions per course, administered twice daily for five days.
- Conventional Drug Group:Participants will receive pantoprazole (40 mg orally once daily) and itopride (50 mg orally three times daily) for four weeks.
Participants:
The study will enroll 150 adult outpatients (aged 18-70 years) diagnosed with functional dyspepsia according to the Rome IV criteria. Participants will be screened based on specific inclusion and exclusion criteria and will provide informed consent before enrollment.
Data Management and Statistical Analysis:
All data will be collected and analyzed using SPSS 19.0 software. The analysis will include t-tests for normally distributed data and non-parametric tests for non-normally distributed data. The study will also employ multifactor ANOVA to assess the impact of various factors on treatment outcomes.
Ethical Considerations:
The study will be conducted in accordance with ethical standards, ensuring participant confidentiality and safety. Adverse events will be closely monitored and reported to relevant regulatory bodies.
This study aims to provide evidence for the clinical efficacy of TBS in treating FD, potentially offering a new therapeutic approach for managing brain-gut axis-related disorders.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 70 years old, regardless of gender, outpatients.
- Meets the Rome IV diagnostic criteria for functional dyspepsia in gastroenterology (2016 edition).
- There are symptoms of postprandial fullness discomfort, early satiety discomfort, mid-upper abdominal pain, and mid-upper abdominal burning discomfort, with at least one score (degree + frequency) ≥ 4 points; the total score is ≥ 10 points. Note: See the case report form for the scoring table.
- Agree to participate in this clinical trial and sign the informed consent form.
Key exclusion criteria (4 listed)
- Those who suffer from organic gastrointestinal diseases such as reflux esophagitis, peptic ulcer, gastrointestinal tumors, etc., or who are suspected of having intestinal obstruction.
- Patients with intracranial hypertension, epilepsy, severe heart disease, other serious physical diseases or cognitive dysfunction; pregnant and lactating women.
- ALT and AST are greater than 1.5 times the normal value, total bilirubin exceeds 1.5 times the upper limit of the normal value, and creatinine exceeds the upper limit of the normal value;
- Suspected or confirmed history of drug or alcohol abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic thetaburst stimulation （TBS）Also: Conventional drugsTBS group: iTBS was administered to stimulate RMFC, 80-100% RMT, 10 times a course, twice a day, for a total of 5 days; Conventional drugs group: pantoprazole 40 mg orally once a day; itopride 50 mg orally three times a day; treatment for 4 weeks. （Standard medication regimen） | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic thetaburst stimulation （TBS） in people with Functional Dysphonia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.